Preparation Process And Quality Standards. Sleep Safety Dropping Pills

Insomnia means having difficulties in falling and staying asleep, causing thequality and quantity of sleep cannot meet the physiological need, cause that patientsself inductance fail the abundant rest and resume energy in varying degrees in thedaytime, therefore feel fatigue, gloominess, giddiness, palpitation, sleepiness,attention fails, hard to concentrate, thinking difficulties, memory fails, slowingresponses, and irritability. The insomnia is the most common form of sleeping-disorder somnipathy. With the quickening rhythm of modern lifestyle, there is trend ofincrease in the frequency of insomnia. As insomnia seriously affects people's life,work and physical and mental health, Traditional Chinese Medicine with its originaladvantage in treating insomnia receives the medicinal worker's attention. People's normal sleep is controlled by the heart to Traditional Chinese medicine,sleep is the result of yang transforming into inactive from active and going out ofsleep is the result of yang transforming into active. The normal sleep is the result ofnatural and harmonious transformation of yin and yang. Once this kind of harmony isdestroyed, insomnia begins to emerge. The main mechanism of the insomnia is thedisharmony between internal organs yin and yang, between qi and blood, these in turncause the unstableness of mind and insomnia. Mian'er'an dripping pills, the subject ofcurrent study, is the traditional Chinese medicine preparation mainly to treat anxiousinsomnia, nocturnal emission and involuntary emission and melancholy insomniacaused by the deficiency of yin and blood in the kidney and heart. This Chinese herbalpreparation is an effective prescription in clinical practice and consists of following 4herbs, Fructus Schisandrae Chinensis(Wu Wei Zi) , Semen Ziziphi Spinosae(Suan ZaoRen), Poria(Fu Ling), Cortex Albiziae(He Huan Pi). The current study focused on pharmaceutical technology, quality standard andAbstract 5preliminary pharmacodynamics appraisal. In the study of pharmaceutical technology,we optimized the preparation process with the method of orthogonal experiment andstudied the shaping process to establish the preparation process. In the study ofquality standard, TLC of Semen Ziziphi Spinosae and Cortex Albiziae wereestablished. The method of determining Schisandrin by HPLC was also establishedand the content range of Schisandrin in the raw materials and preparation wasstipulated. The 3-month stability of Mian'er'an dripping pills had been observed too and theresult indicated that its quality is steady within three months. The DifferentialScanning Calorimetery (DSC) was performed to compare the difference betweendripping pills made of Fructus Schisandrae Chinensis extraction by 90% alcohol andthose by water. DSC Pictures indicated that the heat absorption peak of FructusSchisandrae Chinensis is 186.8℃ and that of PEG is 63.4℃, physical mixtures ofthese two extractions and PEG basically kept the heat absorption peak; yet picturesfrom dripping pills show that the heat absorption peak of PEG does not change but thepeak of Fructus Schisandrae Chinensis virtually disappeared. Preliminary analyzeindicated that this medicine was already wrapped up by the carrier.